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    <tradeName>00884883004580</tradeName>
    <deviceName>QMS Everolimus Cal Kit ROW</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080606</emdnCode>
    <emdnDescription>EVEROLIMUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0373860</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:20:18.246Z</lastUpdated>
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    <udiDi>00884883004573</udiDi>
    <basicUdiDi>B-00884883004573</basicUdiDi>
    <tradeName>00884883004573</tradeName>
    <deviceName>QMS Everolimus Reagent ROW</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080606</emdnCode>
    <emdnDescription>EVEROLIMUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0373852</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:20:14.251Z</lastUpdated>
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    <udiDi>00884883001848</udiDi>
    <basicUdiDi>B-00884883001848</basicUdiDi>
    <tradeName>00884883001848</tradeName>
    <deviceName>MAS Mycophenolic Acid Liquid Assayed Mycophenolic Acid Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>MYCOPHENOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100280</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:56.288Z</lastUpdated>
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    <udiDi>00884883001831</udiDi>
    <basicUdiDi>B-00884883001831</basicUdiDi>
    <tradeName>00884883001831</tradeName>
    <deviceName>MAS Mycophenolic Acid Liquid Assayed Mycophenolic Acid Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080605</emdnCode>
    <emdnDescription>MYCOPHENOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100279</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:54.686Z</lastUpdated>
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    <udiDi>00884883001824</udiDi>
    <basicUdiDi>B-00884883001824</basicUdiDi>
    <tradeName>00884883001824</tradeName>
    <deviceName>MAS Mycophenolic Acid Liquid Assayed Mycophenolic Acid Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080605</emdnCode>
    <emdnDescription>MYCOPHENOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100278</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:52.287Z</lastUpdated>
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    <udiDi>00884883001817</udiDi>
    <basicUdiDi>B-00884883001817</basicUdiDi>
    <tradeName>00884883001817</tradeName>
    <deviceName>CEDIA Mycophenolic Acid Calibrators</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080605</emdnCode>
    <emdnDescription>MYCOPHENOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100277</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:50.701Z</lastUpdated>
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    <udiDi>00884883001800</udiDi>
    <basicUdiDi>B-00884883001800</basicUdiDi>
    <tradeName>00884883001800</tradeName>
    <deviceName>CEDIA Mycophenolic Acid</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080605</emdnCode>
    <emdnDescription>MYCOPHENOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100276</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:49.897Z</lastUpdated>
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    <udiDi>00884883001589</udiDi>
    <basicUdiDi>B-00884883001589</basicUdiDi>
    <tradeName>00884883001589</tradeName>
    <deviceName>CEDIA CsA PLUS Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080601</emdnCode>
    <emdnDescription>CYCLOSPORINE TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100147</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:09.017Z</lastUpdated>
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    <udiDi>00884883001312</udiDi>
    <basicUdiDi>B-00884883001312</basicUdiDi>
    <tradeName>00884883001312</tradeName>
    <deviceName>CEDIA Gentamicin II Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080307</emdnCode>
    <emdnDescription>GENTAMICIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:18.565Z</lastUpdated>
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    <udiDi>00884883001305</udiDi>
    <basicUdiDi>B-00884883001305</basicUdiDi>
    <tradeName>00884883001305</tradeName>
    <deviceName>Valproic Acid II</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080210</emdnCode>
    <emdnDescription>VALPROIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:16.142Z</lastUpdated>
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    <udiDi>00884883001299</udiDi>
    <basicUdiDi>B-00884883001299</basicUdiDi>
    <tradeName>00884883001299</tradeName>
    <deviceName>CEDIA Cyclosporine PLUS High Range Calibrators (450/2000)</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080601</emdnCode>
    <emdnDescription>CYCLOSPORINE TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:14.544Z</lastUpdated>
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    <udiDi>00884883001275</udiDi>
    <basicUdiDi>B-00884883001275</basicUdiDi>
    <tradeName>00884883001275</tradeName>
    <deviceName>CEDIA Theophylline II Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080402</emdnCode>
    <emdnDescription>THEOPHYLLINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:13.746Z</lastUpdated>
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    <udiDi>00884883001251</udiDi>
    <basicUdiDi>B-00884883001251</basicUdiDi>
    <tradeName>00884883001251</tradeName>
    <deviceName>CEDIA Carbamazepine II</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080201</emdnCode>
    <emdnDescription>CARBAMAZEPINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:09.748Z</lastUpdated>
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    <udiDi>00884883001237</udiDi>
    <basicUdiDi>B-00884883001237</basicUdiDi>
    <tradeName>00884883001237</tradeName>
    <deviceName>CEDIA Phenobarbital II Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080207</emdnCode>
    <emdnDescription>PHENOBARBITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:08.141Z</lastUpdated>
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    <udiDi>00884883001220</udiDi>
    <basicUdiDi>B-00884883001220</basicUdiDi>
    <tradeName>00884883001220</tradeName>
    <deviceName>CEDIA Phenytoin II Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080208</emdnCode>
    <emdnDescription>PHENYTOIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:07.351Z</lastUpdated>
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    <udiDi>00884883001206</udiDi>
    <basicUdiDi>B-00884883001206</basicUdiDi>
    <tradeName>00884883001206</tradeName>
    <deviceName>DRI Digoxin Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1669</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:03.355Z</lastUpdated>
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    <udiDi>00884883000704</udiDi>
    <basicUdiDi>B-00884883000704</basicUdiDi>
    <tradeName>00884883000704</tradeName>
    <deviceName>QMS® Lidocaine (LIDO) Calibrators</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080105</emdnCode>
    <emdnDescription>LIDOCAINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0374678</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:13.668Z</lastUpdated>
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    <udiDi>00884883000537</udiDi>
    <basicUdiDi>B-00884883000537</basicUdiDi>
    <tradeName>00884883000537</tradeName>
    <deviceName>QMS Everolimus Immunoassay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080606</emdnCode>
    <emdnDescription>EVEROLIMUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0380005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:12.866Z</lastUpdated>
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    <basicUdiDi>B-00858724003339</basicUdiDi>
    <tradeName>ARK Lacosamide Assay</tradeName>
    <deviceName>ARK Lacosamide Assay</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080299</emdnCode>
    <emdnDescription>CENTRAL NERVOUS SYSTEM TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5033-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:01.484Z</lastUpdated>
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    <udiDi>00858724003223</udiDi>
    <basicUdiDi>B-00858724003223</basicUdiDi>
    <tradeName>ARK Voriconazole II Assay</tradeName>
    <deviceName>ARK Voriconazole II Assay</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102080399</emdnCode>
    <emdnDescription>ANTIBIOTICS TDM - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5030-0001-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:38:59.085Z</lastUpdated>
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